Abstract
BackgroundAsylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services. Their contact with health care is often crisis-driven and mediated through non-governmental organisations (NGOs).Problem Management Plus (PM+) is a psychosocial intervention recommended by the World Health Organisation to address distress experienced by adults affected by humanitarian crises. We are investigating its application for the first time in a high-income country.MethodsIn a pilot randomised controlled trial (RCT), PM+ will be delivered to AS&Rs in contact with NGOs in Liverpool City Region, UK by lay therapists who have lived experience of forced migration. Following systematic review and stakeholder engagement, PM+ has been adapted to the local context, and lay therapists have been trained in its delivery.We will assess the feasibility of conducting a three-arm RCT of five 90-min sessions of PM+, delivered individually or in groups by lay therapists to AS&Rs experiencing emotional distress and functional impairment, compared with each other and with usual support offered by local NGOs. Distress and impairment at baseline will be measured by the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule (WHO-DAS). We aim to recruit 105 participants, 35 per arm.Primary health outcomes are anxiety and depressive symptoms at 3 months, measured by HADS. Secondary outcomes include subjective wellbeing, functional status, progress on identified problems, presence of post-traumatic stress disorder and depressive disorder and service usage. Longer-term impact will be assessed at 6 months post baseline, on the same parameters.We will assess the feasibility of conducting a full RCT in relation to the following elements: recruitment and retention of lay therapists and study participants; fidelity of delivery of PM+; and suitability of the study measures, including any linguistic or cultural barriers.DiscussionWe will use these findings to specify the parameters for a full RCT to test the effectiveness and cost-effectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees.Trial registrationISRCTN, ID: ISRCTN15214107. Registered on 10 September 2019.
Highlights
Asylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services
We will use these findings to specify the parameters for a full randomised controlled trial (RCT) to test the effectiveness and costeffectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees
The Client Service Receipt Inventory (CSRI) has been adapted for the PROSPER trial to include health, social care and voluntary services with the potential to be used by asylum seekers and refugees
Summary
Aim and objectives This pilot trial is part of the PROSPER feasibility study, the overall aim of which is to determine whether it is possible to conduct a randomised controlled trial (RCT) in the UK of the evidence-based PM+ psychosocial intervention, delivered by lay therapists for distressed and functionally impaired asylum seekers and refugees. The primary objective of the PROSPER Pilot is to provide preliminary information on the potential effectiveness of group or individual PM+ versus standard care for AS&Rs, assessed using severity of combined anxiety and depressive symptoms at 13 weeks post baseline, measured using the Hospital Anxiety and Depression Scale (HADS). The secondary objectives are to provide preliminary information on the potential effectiveness and costeffectiveness of group or individual PM+ versus standard care for AS&Rs with regards to: Severity of combined anxiety and depressive symptoms at 26 weeks. The other inclusion criteria are: Aged ≥ 18 years (self-reported) A score of ≥ 8 on either the depression or anxiety subscale of the HADS [31], and a score of ≥ 17 on the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS) [32] Have conversational English, as self-assessed by the potential participant Being registered with a GP in Liverpool City Region Are willing to provide relevant socio-economic data Have provided written informed consent. HADS has been widely used across cultures; it is sensitive to change over time and has good internal consistency, reliability and validity [38]
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